title: Anti-D immunoglobulin therapy for pediatric ITP: before and after the FDA's black box warning.
abstract: In March 2010, the Food and Drug Administration (FDA) issued a black box warning for anti-D immunoglobulin (anti-D), an approved treatment for immune thrombocytopenia (ITP). It is unknown if and how clinical practice at U.S children's hospitals has since changed. We sought to describe inpatient anti-D usage, laboratory monitoring, and anti-D complications before and after the FDA warning. Using the Pediatric Health Information System, we collected data from 41 children's hospitals. There was a modest but statistically significant decrease in anti-D usage from pre-warning to post-warning. Severe complication rates were very low and did not change appreciably.
authors.affiliation: Pediatric Residency Program, Nationwide Children's Hospital, Columbus, Ohio.
authors.forename: Joel C
authors.initials: JC
authors.lastname: Thompson
authors.forename: Jennifer
authors.initials: J
authors.lastname: Klima
authors.forename: Jenny M
authors.initials: JM
authors.lastname: Despotovic
authors.forename: Sarah H
authors.initials: SH
authors.lastname: O'Brien
mesh_terms: D002648:Child; D006801:Humans; D010818:Practice Patterns, Physicians'; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000188:drug therapy*; D018029:Rho(D) Immune Globulin / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D018029:Rho(D) Immune Globulin
keywords: FDA; ITP; anti-D immunoglobulin; children